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510(k) K223860

Integrity™ Bone Staple Fixation System by Anika Therapeutics, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2023
Date Received
December 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Anika Therapeutics, Inc.

  • K250997 — Integrity™ Implant (June 17, 2025)
  • K231968 — Tactoset® Injectable Bone Substitute (December 20, 2023)
  • K223538 — Integrity Implant (August 17, 2023)
  • K222487 — Anika Tissue Tack Fixation System (May 8, 2023)
  • K223915 — Tactoset (March 29, 2023)
  • K212083 — Tactoset Injectable Bone Substitute (August 31, 2021)
  • K190956 — SCS 17-01 (January 30, 2020)
  • K173008 — SCS 17-01 (December 26, 2017)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)